MDR Technical Documentation Services
An audit-ready technical documentation file to EU MDR Annex I, II and III, built to get your device through Notified Body review and to CE marking.
Regulatory Expertise
In-depth knowledge of EU MDR and the global regulatory landscape.
Practical Compliance Support
Actionable solutions tailored to your product and business needs.
Documentation Guidance
Clear, structured and audit-ready documentation support.
Market Access
Smooth and safe access to the European market.
What Is EU MDR Technical Documentation?
EU MDR technical documentation, often called the technical file, is the complete set of records showing how your device was designed, made, tested and monitored, and how it meets every applicable requirement of the regulation. Its contents are set out in Annex II and Annex III of the MDR.
The regulation requires it to be clear, organised, readily searchable and unambiguous. It is not a one time submission. It is a living record that you must keep up to date for as long as the device is on the market, and retain for at least 10 years after the last device is placed on the market, or 15 years for implantable devices.
Every manufacturer needs medical device technical documentation, whatever the device class. What changes with class is who reviews it and how closely.
Services
- Technical Services For Design And Development Of Medical Devices
- QMS Development and Support
- Risk Management Service
- Training and Educating your Staff
- General Support
- Audit Readiness Plan
- Design Control Requirements for Drug-Device Combination Products
- EU Medical Device Regulation
- Medical Device Testing Service
MDR Technical Documentation Requirements by Device Class
The EU MDR technical file requirements are the same for every class, but the level of review is not:
Class I
the manufacturer prepares the file and keeps it available for the authorities. A Notified Body reviews only the relevant aspects of sterile, measuring and reusable surgical devices.
Class IIa and Class IIb
A Notified Body assesses the technical documentation of representative devices during certification and surveillance.
Class IIb and Class III
the Notified Body assesses the technical documentation of each device.
Whatever the class, your file must be written in a language your Notified Body accepts and must stay consistent with your labelling, risk management and clinical evaluation.
MDR Technical File Checklist
Before submission, check that your technical documentation includes:
Device & Labelling
Device description with intended purpose, classification rule and Basic UDI-DI, plus labels and IFU for every target market.
Design, GSPR & Risk
Design and manufacturing information for all sites and suppliers, a completed GSPR checklist, and a risk management file to ISO 14971.
Verification & Clinical
Verification and validation reports, such as biocompatibility, sterilisation, shelf life and software, plus the CEP, CER and PMCF plan.
PMS & Declarations
PMS plan and PMSR or PSUR, the EU Declaration of Conformity and Authorised Representative details.
What Goes Into an MDR Technical File
MDR technical documentation demonstrates compliance with Annex I, the General Safety and Performance Requirements and is organised following the structure of Annex II, with post market surveillance documentation under Annex III.
Annex I — General Safety and Performance Requirements
Annex I sets out the General Safety and Performance Requirements (GSPRs) every device must meet before it can carry the CE mark. It is organised into three chapters: general requirements on safety and performance, requirements on design and manufacture (chemical, physical and biological properties, infection and microbial contamination, devices with a measuring function, and software, among others), and requirements on the information supplied with the device. The GSPR section of Annex II is where you show, requirement by requirement, how your device meets Annex I, through harmonised standards, Common Specifications, or your own evidence.
Annex II — Technical documentation
- Device description and specification: intended purpose, intended users and patients, operating principle, risk class and the classification rule applied, Basic UDI DI, variants, configurations, accessories, and key materials and components.
- Information supplied by the manufacturer: labels on the device and packaging, and the Instructions for Use in the languages of the countries where the device will be sold.
- Design and manufacturing information: design stages, manufacturing processes and their validation, and every site involved, including suppliers and subcontractors.
- General Safety and Performance Requirements (GSPR): how the device meets each applicable requirement of Annex I, the standards or Common Specifications used, the evidence for each, and a justification for any requirement that does not apply.
- Benefit risk analysis and risk management: the risk management process under ISO 14971, risk controls and their results, and the conclusion that benefits outweigh residual risks.
- Product verification and validation: pre clinical testing such as biocompatibility, electrical safety, software, sterilisation, shelf life and usability, plus the Clinical Evaluation Plan and Report, and the PMCF plan where applicable.
Annex III — Post market surveillance documentation
- Post market surveillance: the PMS plan, and the Post Market Surveillance Report (Class I) or Periodic Safety Update Report (Class IIa and above), showing how real world data feeds back into risk management and clinical evaluation.
Administrative documents complete the file: the EU Declaration of Conformity, certificates, and Authorised Representative details for non EU manufacturers.
Technical Documentation for Drug Device Combination Products
Combination products need documentation that satisfies both device and medicine regulators.
- Integral products regulated as medicines, such as prefilled syringes, pen injectors and auto injectors: under Article 117, the marketing authorisation application must show the device part meets the relevant GSPRs, through a CE certificate or a Notified Body Opinion. The device documentation typically covers dose accuracy, container closure and drug compatibility, and usability, with reference to standards such as ISO 11608 for pen injectors and ISO 11040 for prefilled syringes.
- Devices with a supporting medicinal substance, such as drug coated devices: these are Class III devices, and the technical documentation must include data on the medicinal substance so the Notified Body can consult a medicines authority.
This is where 3i Concept’s pharmaceutical and device experience makes the biggest difference.
Our Process
Manufacturers most often run into:
- Gap assessment: we run an MDR gap analysis on your existing technical documentation against Annex II and III.
- Classification and route: we confirm the device class and conformity assessment route.
- Build or restructure: we prepare missing documents and organise the file in the Annex II and III structure
- Consistency review: we cross check the IFU, risk management, GSPR and clinical evaluation against each other.
- Submission support: we support your Notified Body submission and help answer review questions.
- Maintenance: we keep the file current as post market data, standards and designs change.
Our Medical Device Technical Documentation Services
- Complete technical file preparation to Annex II and III, from scratch
- Medical device technical documentation review services: gap assessment and restructuring of existing files
- GSPR checklist preparation with traceable evidence, starting from a GSPR checklist template where useful
- Risk management file preparation aligned with ISO 14971
- Design controls and Design History File support, including a design history file template you can adapt, linking design records to your technical file
- Clinical Evaluation Report preparation and review acting as your clinical evaluation report consultant to keep the CER aligned with the rest of the technical file
- Testing and performance support, including drug device testing strategy, compatibility and sterility studies, as part of our broader medical device validation services
- Combination product documentation for Article 117 Notified Body Opinions
- QMS support aligned with ISO 13485
- Notified Body submission and query response support
- Audit readiness and ongoing technical file maintenance
Subhash Meena
Medical Device & Drug-Device Combination Product Expert
Why Choose 3i Concept
Our technical documentation work is led by Subhash Meena, a Medical Device and Drug Device Combination Product expert with 15+ years of experience at Meril Life Sciences, Sun Pharmaceutical Industries, Amneal Pharmaceuticals and Dr. Reddy’s Laboratories, across cardiology, orthopaedics and endosurgery devices.
His direct Notified Body and USFDA filing experience means your file is prepared by someone who knows what reviewers check. For manufacturers considering EU MDR technical documentation outsourcing, that means one expert partner for the whole file, including the combination product elements most consultancies do not cover.
15+
Year of Experience
4
Leading Companies
NB + USFDA
Direct Fillings
Frequently Asked Questions
The complete set of records, defined in Annex II and III of Regulation (EU) 2017/745, that shows a medical device meets all applicable MDR requirements. It is the main evidence reviewed for CE marking.
Yes. Every manufacturer must prepare and maintain technical documentation before placing a device on the EU market, whatever its class.
Annex I sets out the General Safety and Performance Requirements (GSPRs) every device must meet. Annex II covers the device itself: description, labelling, design and manufacturing, evidence of GSPR compliance, risk management, and verification and validation. Annex III covers post market surveillance documentation: the PMS plan and the PMSR or PSUR.
At least 10 years after the last device is placed on the market, or 15 years for implantable devices.
For Class I devices, the manufacturer keeps the file available for the authorities, with limited Notified Body review for sterile, measuring and reusable surgical devices. For Class IIa, IIb and III devices, a Notified Body reviews it, with Class III and Class IIb implantable devices reviewed for each device.
A Design History File records how the device was designed and is a US FDA concept. The EU MDR technical file includes design information but also covers GSPR, risk management, clinical evaluation, labelling and post market surveillance. A well kept Design History File — built from a design history file template if you’re starting fresh — makes the technical file much easier to build.
It depends on the device class, how much evidence already exists, and whether testing or clinical data is still needed. A gap assessment at the start gives you a realistic timeline.
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